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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceANIMAS VIBE SYSTEM
Generic NameSensor, glucose, invasive
ApplicantANIMAS CORP.
965 CHESTERBROOK BLVD.
WAYNE, PA 19087
PMA NumberP130007
Supplement NumberS002
Date Received03/26/2015
Decision Date06/22/2015
Withdrawal Date 06/11/2020
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR SUBSTITUTION OF 4 COMPONENTS (MEMORY, TRANSISTOR, MICRO-PROCESSING UNIT, CONNECTOR) ON THE PRINTED CIRCUIT BOARD (PCB) OF THE APPROVED ANIMAS VIBE INSULIN PUMP. ONE OF THE REPLACEMENT COMPONENTS (MICRO-PROCESSING UNIT) REQUIRES A MODIFICATION TO THE PCB LAYOUT.
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